Kornimate/medical-research-clean huggingface dataset:
hiv point-of-care test evaluation in infants

Conditions: HIV

Summary: hiv point-of-care tests in babies study (baby) - operational evaluation of hiv point-of-care tests for very early infant hiv diagnostics in infants born to hiv infected mothers in mbeya, tanzania.

this in-vitro diagnostic (ivd) study in infants born to hiv infected mothers evaluates the reliability and operational feasibility of an hiv point-of-care (poc) test for hiv early infant diagnosis (eid) in a public health setting at obstetric clinics in mbeya, tanzania. recruitment is planned to take place at 4 obstetric/maternity study sites in and around mbeya over a time period of 12 months. the hiv poc test will be validated against the standard-of-care diagnostic test, i.e. dried blood spot (dbs) analyses. the poc test under investigation is the xpert hiv-1 qual produced by cepheid, sunnyvale, usa.

Eligibility criteria:
inclusion criteria: 1. voluntary and informed consent of the mother for her own study participation (if applicable). 2. voluntary and informed consent of the legal guardian of the child for participation of the child in the study. 3. mothers/legal guardians ≥18 years of age. 4. documented maternal hiv infection. 5. willingness to consent to hiv testing for the child and herself (if applicable). 6. willing to consent to active tracing including home tracing. exclusion criteria: 1. deficiency in the mother, rendering it difficult, if not impossible, for her or her infant to take part in the study or understand the information provided to her. this includes alcoholism, drug dependency as well as psychiatric illnesses, suicidal tendencies or any other inability. 2. having delivered more than 48h ago 3. prisoners 4. women presenting with an emergency requiring immediate medical assistance if not resolved at study inclusion. 5. stillbirths 6. infant requiring emergency care or born with severe malformation. 7. if within the discretion of the investigator based on recommendation of the gynaecologist or paediatrician in charge study participation would possibly add not acceptable risk or burden to the mother or infant (e.g. significant congenital malformation, health deficiencies, very low birth weight less than 1500g) 8. unlikely to comply with protocol as judged by the principal investigator or his designate

Keywords: in-vitro diagnostics paediatrics
gentamicin intravesical efficacy for infection of urinary tract

Conditions: Postoperative Urinary Tract Infection; Pelvic Organ Prolapse; Stress Urinary Incontinence

Summary: urinary tract infection (uti) is a common problem after surgery for pelvic organ prolapse and stress urinary incontinence. this prospective, randomized, single-masked (subject), two-parallel armed study aims to determine the effect of a single postoperative intravesical instillation of 80 mg of gentamicin sulfate in 50 ml of saline versus usual care on the proportion of women treated for uti within 6 weeks following surgery for pelvic organ prolapse (pop) or stress urinary incontinence (sui).


Eligibility criteria:
inclusion criteria: * adult women undergoing pelvic organ prolapse surgery and/or stress urinary incontinence surgery with surgical plan for at least 1 cystoscopy and will leave the operating room with a standard-of-care transurethral catheter. * negative urine culture within 4 weeks or completion of uti treatment ≥48 hours prior to surgery exclusion criteria: * history of allergic reaction or anaphylaxis to gentamicin sulfate or to sodium metabisulfite (one of the preservatives in the gentamicin sulfate product) * abnormal intraoperative urinary tract finding (e.g. bladder mass, stone, or fistula) * intraoperative urinary tract injury * suppressive recurrent uti treatment * chronic indwelling catheter/self-catheterization * unable to provide informed consent * severe renal impairment - glomerular filtration rate of less than 30 ml / minute * current pregnancy * currently incarcerated

Keywords: gentamicin sulfate pelvic organ prolapse surgery midurethral sling bladder instillation
reducing 30-day sepsis readmissions: impact of a post discharge education program

Conditions: Sepsis

Summary: this study will advance the knowledge in the field by determining the effectiveness of discharge education regarding prevention of a new infection which is the highest cause of readmission for sepsis patient. in evaluating the impact care teams will develop a clearer link between specific home-based education interventions and infection prevention. this study is an exploratory study designed to identify whether patient education through an innovative teaching method can have an impact on readmissions. this study may the first of several based on findings from this initial, exploratory study.


Eligibility criteria:
inclusion criteria: * oncology patients discharged to home following a diagnosis of sepsis, severe sepsis or septic shock * patient must have a mobile phone/device * english speakers * age range 18 - 85 years exclusion criteria: * less than 18 years of age and older than 85 years of age * no mobile phone/device * non-english speaking * no diagnosis of sepsis, severe sepsis, or septic shock * non-oncology patient

Keywords: sepsis education cancer
endothelial injury mechanism in elderly patients undergoing major surgery

Conditions: Endothelial Dysfunction; Blood Brain Barrier Defect; Postoperative Cognitive Dysfunction

Summary: the incidence of postoperative cognitive injury is high in elderly patients, especially after major surgery. the relevant pathophysiological mechanisms are still unclear, and the possible mechanisms that have been proposed so far include inflammation, neurotransmitter imbalance and metabolic disorders. in recent years, clinical studies of acute brain dysfunction after vascular endothelial injury have attracted attention. degradation of the endothelial glycocalyx layer and subsequent shedding of its constituents is seen as an early marker of endothelial injury, and may increase vascular permeability.many preclinical and clinical studies have demonstrated an association between inflammatory cytokines such as tnf-α, il-1β, il-6, and il-10 and glycocalyx degradation biomarkers. the scholars found evidence of plasma endothelial injury after abdominal open surgery in the elderly. dexmedetomidine could attenuate stress response such as tnf-α, il-1β and il-6. based on the above evidence, we hypothesize that elderly patients experience inflammatory response secondary to surgical traumatic stress after major surgery, greatly increasing the degree of endothelial injury (heparan sulphate and syndecan-1), reducing brain perfusion while increasing blood-brain barrier permeability (s100b level), promoting the release of cytokines interleukin-2(il-2), interleukin-6(il-6), tumor necrosis factor-alpha(tnf-α) ,and vascular endothelial growth factor (vegf) while reducing brain-derived neurotrophic factor(bdnf) synthesis, then leading to postoperative acute spasm. we would test the hypothesis that can reverse these effects and improve cognitive deficits.


Eligibility criteria:
inclusion criteria: 1. written informed consent; 2. patients undergoing selective major gastrointestinal surgery with laparoscope and general anesthesia; 3. age 65-90 yrs; 4. anesthesia society of american (asa) scale ii\~iv; 5. anticipated surgery time 2-6 hrs; exclusion criteria: 1. dementia patients（mini-mental state examination\< 20） 2. factors existed that affect cognition assessment such as language,visual,and auditory dysfunction； 3. unstable metal status and mental disease； 4. a hematocrit value less than 28%in perioperative period; 5. patients with abnormal preoperative inflammatory indicators（higher white blood cell and c-reactive protein); 6. patients undergoing cardiac and neural surgery; 7. parkinson's disease； 8. sure or suspected abuse of analgesic and sedation drug.
clinical application of non-invasive pgt-a

Conditions: Genetic Testing

Summary: the study aims to investigate the difference of in vitro fertilization (ivf) outcomes among non-invasive pgt-a, pgt-a and combined non-invasive pgt-a and pgt-a.

background chromosome abnormality is a leading cause of implantation failure and miscarriage. chromosome abnormality increases with age, resulting in reduced pregnancy rate. nowadays, preimplantation genetic testing for aneuploidies (pgt-a) could be used for detection of aneuploidy. however, pgt-a needs embryo biopsy which is invasive and may cause embryo damage. it was found that cell free dna could be isolated from culture media. the cell free dna from culture media also could be used to detect embryo ploidy, called non-invasive pgt-a. objective the study aims to investigate the difference of in vitro fertilization (ivf) outcomes among non-invasive pgt-a, pgt-a and combined non-invasive pgt-a and pgt-a. another aim of this study is to check the concordance rate between non-invasive pgt-a and pgt-a. methods the prospective cohort study will be performed at the reproductive medical center of kaohsiung veterans general hospital, in kaohsiung, taiwan. participants who plan to receive an ivf cycle and preimplantation genetic testing for aneuploidies will be enrolled in this study. the investigators will divide the participants into 3 groups: (1) combined non-invasive pgt-a and pgt-a; (2) pgt-a; (3) non-invasive pgt-a. basal characteristics, infertility history, ovarian reserve and embryo development of the three groups will be recorded. the samples will be detected ploidy by using next generation sequencing (ngs). then, the investigators will choose embryo to transfer according to the embryo ploidy and follow the pregnancy outcomes after embryo transfer. outcome 1. concordance rate between non-invasive pgt-a and pgt-a 2. the relationship between morphological grade and ploidy of non-invasive pgt-a 3. ivf outcomes among non-invasive pgt-a, pgt-a and combined non-invasive pgt-a and pgt-a

Eligibility criteria:
inclusion criteria: * infertile women who undergo ivf with pgt * bmi:18\~30 kg/m2 exclusion criteria: * primary ovarian insufficiency * congenital uterine anomaly * severe male infertility (azoospermia) * one of the couples with chromosome abnormality * malignancy

Keywords: pgt pgt-a non-invasive pgt-a embryo biopsy spent media cell free dna
a pilot study to evaluate radiotherapy-induced anti-tumor immunity in metastatic carcinoma of the pancreas

Conditions: Histological or Cytological Diagnosis of Pancreatic Carcinoma

Summary: primary objective: to estimate the rate at which radiotherapy to the primary or a metastatic lesion produces an immune response in patients with metastatic carcinoma of the pancreas. secondary objectives: to characterize the kinetics of an immune response induced by radiotherapy. to characterize the dependency of the immune response on prior exposure to chemotherapy.


Eligibility criteria:
inclusion criteria: * histological or cytological diagnosis of pancreatic carcinoma * patients ≥ 18 years of age * eastern cooperative oncology group (ecog) performance status 0,1,or 2 * patients must have distant metastatic disease (stage 4) * satisfactory organ and bone marrow function as defined by: absolute neutrophil count\> 1,000/ul, platelets \> 75,000ul hemoglobin \> 9 bilirubin ≤ 2.0x the institutional normal upper limit unless secondary to bile duct obstruction by tumor, * creatinine ≤ 1.5x the institutional normal upper limit * serum alanine aminotransferase (alt) or aspartate aminotransferase (ast) ≤ 5x the institutional normal upper limit. * a clinical recommendation for radiotherapy to the primary or a metastatic lesion had been made. * must be able to provide informed consent. exclusion criteria: * no prior radiation to the area planned for radiotherapy * active invasive cancer other than pancreatic adenocarcinoma. non-melanoma skin cancer, superficial cervical or bladder cancer and prostate cancer with psa level \< 1.0 are not excluded. * known hiv, hcv and/or hbv positive (by patient report/medical record) * patients with ongoing or active infection * planned concurrent treatment with systemic high dose corticosteroids. * received an anticancer treatment (systemic therapy or radiation therapy)within 21 days prior to enrollment. * immunotherapy (e.g. monoclonal antibodies)within 21 days prior to enrollment. * immunosuppressive therapies (e.g. steroids, cyclosporine) are not permitted.
intravascular lithotripsy in high risk calcified iliac anatomy for transfemoral tavr

Conditions: Iliac Disease; Aortic Valve Stenosis

Summary: to assess the efficacy and safety of intravascular lithotripsy (ivl) in subjects undergoing transfemoral tavr in patients with severe iliac disease, prohibitive for transfemoral tavr in patients with severe symptomatic aortic stenosis, otherwise considered for alternative access tavr. (e.g. trans-carotid)

the goal of this post-market, prospective, observational single-arm cohort study is to assess the efficacy and safety of intravascular lithotripsy (ivl) in subjects undergoing transfemoral tavr in patients with severe iliac disease, prohibitive for transfemoral tavr in patients with severe symptomatic aortic stenosis, otherwise considered for alternative access tavr. (e.g. trans-carotid). this is a study of patients referred to bsw the heart hospital, plano for evaluation of critical aortic stenosis. those planned to undergo tavr, have prohibitive iliofemoral disease, and otherwise considered for alternative access, will be considered for the study. the medical devices being used are in the post-market stage as it is being used in accordance with its approved labeling, treating iliofemoral disease. study data will be recorded prospectively on dedicated data collection forms and stored locally in a secure format. de-identified data will be uploaded for statistical analysis. irb approval for the study will be obtained.

Eligibility criteria:
inclusion criteria: 1. age 18 to 90 years of age, inclusive, at the time of signing the informed consent 2. iliofemoral disease warrants treatment, per routine guidelines (greater than 50% stenosis and heavy calcification of the iliac's). 3. severe symptomatic aortic stenosis and undergoing a planned tavr procedure 4. prohibitive iliofemoral disease, as determined by the diagnostic ct abdomen and pelvis. 5. subjects can provide written, informed consent. exclusion criteria: 1. subject is participating in another research study involving an investigational agent that has not reached the primary endpoint. 2. subject who has contraindications to ivl 3. subject who has contraindications or is not eligible for tavr
newborn phosphocalcic metabolism after intravenous iron administration during pregnancy

Conditions: Iron Induced Hypophosphatemia

Summary: iron deficiency anemia (ida) is a very common health problem during pregnancy and intravenous (iv) iron substitution has become part of routine management. recent studies have raised concerns about association of iv iron infusion and development of secondary transitory hypophosphatemia (hp) in adults including pregnant women. the study aimed to evaluate the impact of iv iron administration during pregnancy on newborn's phosphatemia. the investigators conducted a prospective, single-center, observational study in the geneva university hospitals (hug), from september 2022 to march 2023. pregnant women treated either with iv iron or with oral iron during pregnancy were included. at delivery, a maternal blood sample to assess hemoglobin, hematocrit, ferritin, phosphate and calcium and an umbilical cord blood sample to assess levels of phosphate and calcium were collected. difference in demographics and clinical characteristics between the two groups were explored using univariate analyses. multivariate analyses were performed to test the contribution of iv iron substitution on cord blood phosphatemia and calcemia, considering potential confounding factors. neonatal hp was defined as a phosphate level lower than 1.3 mmol/l.


Eligibility criteria:
inclusion criteria: * single pregnancy * term (\>37sa) pregnancy * oral or iv iron substitution from second trimester exclusion criteria: * multiple pregnancy * fetal anomalies * preterm birth
tavr without predilatation

Conditions: Aortic Stenosis

Summary: the procedure is performed via transfemoral or transcaprotid access; patients were confirmed to be eligible for tavr by a multidisciplinary heart team including at least an interventional cardiologist, a cardiothoracic surgeon and an anesthetist. all tavr implantation procedures were performed with the edwards sapien 3 thv or the medtronic corevalve evolut . for all patients, both vascular access and aortic valve were evaluated before the procedure by multislice computerized tomographic angiography (msct) of the entire aorta using vascular windows settings. the prosthesis and the vascular access were left to the discretion of the operating team. transfemoral access was the first choice when possible. all tavr procedures were performed in the same hybrid room (in montpellier university hospital), most tavr were performed under sedation or general anesthesia using mild low profile 14-16 french delivery systems and using percutaneous or surgical vascular access.


Eligibility criteria:
inclusion criteria: - patients undergoing tavr via transfemoral or rascoarotid access exclusion criteria: - others access (subclavian, apical, transaortic)

Keywords: tavr balloon prediltation success of crossing the valve direct implanation
clinical trial of transdiagnostic cognitive-behavior therapy for anxiety disorders

Conditions: Panic Disorder; Agoraphobia; Social Anxiety Disorder; Generalized Anxiety Disorder

Summary: anxiety disorders are the most common mental disorders in community settings, and they are associated with significant psychological distress, functional and social impairment. although pharmacological and psychological treatments for anxiety and depression have existed for several years now, only a minority of anxiety disorder sufferers are treated according to guidelines. cognitive behavior therapy (cbt) is the most consistently efficacious psychological treatment for anxiety disorders, but implementation of cbt in primary care is challenging due to limited resources. recent studies indicate that transdiagnostic group cbt for multiple anxiety disorders could be a promising alternative to individual cbt in primary care. the aim of the study is to examine the effectiveness of group cbt for anxiety disorders as a complement to usual care. the clinical trial will be conducted in three health and social services centers in the province of québec (i.e. sherbrooke, laval and québec). patients will be french-speaking adults with anxiety disorders, and they will be randomly assigned to one of two treatment conditions: a) transdiagnostic group cbt (12 weekly 2-hour sessions), b) usual care. the transdiagnostic group cbt will be offered as a differed intervention to participants in the usual care group after the 8-month follow up. participants in both study arms will undergo a baseline clinical evaluation as well as outcome assessment interviews at post-treatment, 4, 8, and 12 month follow-up time-points. the primary study results will include improvement on a questionnaire on anxiety symptoms. widespread implementation of group cbt could lead to better outcomes for a large number of patients living with anxiety.


Eligibility criteria:
inclusion criteria: * aged 18-65 (upper age limit added 2016-11-18) * fluent in spoken and written french. * meeting dsm-5 diagnostic criteria for at least one of the following anxiety disorders as a primary mental disorder: panic disorder, agoraphobia, generalized anxiety disorder and/or social anxiety disorder according to a clinical rating ≥ 4 for the anxiety disorders interview schedule for dsm-5 (adis-5) administered by a trained phd-level clinician. exclusion criteria: * active suicidal intentions, psychosis, bipolar disorder, active substance-related disorder and addictive disorder in the past 12 months (sections or screening questions in adis-5). * marked cognitive impairment \[épreuve des 5 mots (dubois, 2002) administered in case of doubt by assessor\]. * consultation with a psychiatrist in the past 12 months.

Keywords: panic disorder agoraphobia social anxiety disorder generalized anxiety disorder cognitive-behavioral therapy
analysis of methicillin resistant staphylococcus aureus (mrsa) obtained through the emergency department in a tertiary care hospital in vancouver canada from 2001-2005

Conditions: Infection With MRSA Bacteria

Summary: to analyze microbiological data from mrsa samples obtained through the emergency department from 2001-2005. there is a strong clinical suspicion that we are now seeing an outbreak of a new strain of mrsa and we plan to better characterize the vancouver population and complete a chart review to assess specific associated factors.

pulse field gel electrophoresis, scc mec typing, antibiotic susceptibilities, presence of the panton-valentine leukocidin gene will be carried out. clinical manifestations and associated factors will be assessed via chart review. these include: recent antibiotic use, recent hospitalization, iv drug use, hiv status, number of co-morbidities identified, presence of soft tissue abscess, post operative status, presence of bacteremia, residence in vancouver's downtown eastside (an area of particularly low socioeconomic status).

Eligibility criteria:
inclusion criteria: * patient had a microbiological sample submitted from the emergency department of the study hospital from 2001- 2005 which grew mrsa.

Keywords: mrsa, usa300, cmrsa-10, cmrsa-6, soft tissue abscesses
a study of high risk localized prostate cancer participants treated with radical prostatectomy and perioperative hormonal therapy

Conditions: High Risk Localized Prostate Cancer

Summary: the purpose of this study is to evaluate the yearly conditional prostate-specific antigen (psa) progression-free survival (pfs) probabilities in high-risk localized prostate cancer (hr lpc) participants following radical prostatectomy (rp) and perioperative hormonal therapies (that is, hormonal treatment before rp and / or after rp) over 5 years.


Eligibility criteria:
inclusion criteria: * participants who have histologically confirmed adenocarcinoma of the prostate * participants newly diagnosed between 1 january 2015 to 30 june 2017 (both dates inclusive) * participants fulfil high-risk localized prostate cancer defined by national comprehensive cancer network (nccn) prostate cancer guideline (2020 version 1) a. t3a or; b. grade group 4 or grade group 5 or; c. prostate specific antigen (psa) greater than (\>) 20 nanograms per milliliter (ng/ml) * participants must have received radical prostatectomy (rp) between 1 january 2015 and 30 june 2017 * participants must have received at least one perioperative hormonal therapy pattern as listed below: 1. greater than or equal to (\>=) 3 months neoadjuvant hormonal therapy, duration between date of last dose and date of rp should be less than or equal to (\<=) 2 months; and/or 2. \>= 6 months adjuvant hormonal therapy, first dose started within 6 months of rp surgery exclusion criteria: * distant metastasis based on conventional imaging (clinical stage m1) at time of prostate cancer diagnosis
the association between shock index and severity of postpartum blood loss

Conditions: Postpartum Hemorrhage

Summary: the present study aims to determine the relationship between postpartum changes in the shock index and the severity of blood loss and other pph results. blood loss, heart rate and blood pressure will be systematically measured in the postpartum period in all participating women to explore new clinical indicators to identify those requiring clinical intervention for excessive bleeding.


Eligibility criteria:
inclusion criteria: * receive care for vaginal delivery exclusion criteria: * scheduled or transferred for cesarean section * cannot give informed consent * are not willing and/or cannot answer the questionnaire on their background